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The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
Approximately 58 subjects from at least two sites in Sweden will be included. Subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks from baseline. Total time in investigation is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment with ChloraSolv | Other | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChloraSolv | Device | Weekly application of ChloraSolv for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer. | The debriding effect of ChloraSolv® will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives are to evaluate change of devitalised tissue, change in wound area, pain during treatment, condition of the wound, need for sharp debridement and overall evaluation of the product and safety parameters. | The objectives to evaluate change of devitalised tissue and change in wound area will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor. Pain during treatment will be assessed by the patient using a Visual Analogue Scale (VAS) for pain. The condition of the wound, need for sharp debridement, overall evaluation of the product and safety parameters are assessed by the health care professional treating the patient and the information is collected in the Case Report Form (CRF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology Skåne University Hospital Malmö | Malmö | Skåne County | Sweden | |||
| Primary Care Center Tunafors |
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| 12 weeks |
| Eskilstuna |
| Sörmland |
| 63188 |
| Sweden |
| Wästerläkarna Primary Care Center | Gothenburg | Västra Frölunda | 42677 | Sweden |
| Carlanderska Sjukhuset | Gothenburg | Västra Götaland County | 40545 | Sweden |
| Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset | Gothenburg | Västra Götaland County | 41345 | Sweden |
| Närhälsan Olskroken Primary Care Center | Gothenburg | Västra Götaland County | 41665 | Sweden |
| Hudmottagningen Skaraborgs Sjukhus | Skövde | Västra Götaland County | 54185 | Sweden |
| Dept of Orthopaedic Surgery | Mölndal | 43180 | Sweden |
| Sårcentrum Södersjukhuset Stockholm | Stockholm | 11883 | Sweden |